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Sleep Apnea: Age Effects On Prevalence and Natural History

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ClinicalTrials.gov Identifier: NCT00005296
Recruitment Status : Active, not recruiting
First Posted : May 26, 2000
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Edward Bixler, Milton S. Hershey Medical Center

Brief Summary:
To identify the prevalence of sleep apnea in men and its relationship to age, assess the natural history of the disorder, and predict those men at risk.

Condition or disease
Lung Diseases Sleep Apnea Syndromes

Detailed Description:

BACKGROUND:

Sleep apnea is potentially a life-threatening disorder commonly associated with the aging process. Often sleep apnea is accompanied by considerable morbidity for both physical and mental health; the associated excessive daytime sleepiness, cardiovascular abnormalities, and cognitive impairment impact greatly on daytime functioning. In 1990, the prevalence of sleep apnea in the general population was undetermined, and there was much speculation regarding its natural history.

DESIGN NARRATIVE:

For the prevalence study, 4,364 randomly-sampled men selected from the general population and stratified by age were evaluated for risk factors for sleep apnea. A total of 741 men found to be at risk were evaluated in the sleep laboratory to determine the degree, if any, of sleep apnea or sleep disordered breathing. Prior to recording subjects in the sleep laboratory, a thorough history was obtained from each subject and a physical examination completed. All men entering into the first four years of the prevalence portion of the study who were found to have sleep apnea or sleep disordered breathing were reevaluated yearly over a five year period in the natural history part of the study. The natural history portion also included 150 men previously studied in the sleep laboratory for apnea but who were not part of the random sample of 4,000 and who were not part of the prevalence study.


Study Type : Observational
Actual Enrollment : 741 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Apnea: Age Effects On Prevalence and Natural History
Actual Study Start Date : January 1990
Actual Primary Completion Date : January 18, 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources




Primary Outcome Measures :
  1. sleep disordered breathing [ Time Frame: immediately upon time of recording ]
    Apnea/hypopnea index



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
stratified random sample following phone interview
Criteria
stratified random sample based on risk severity for sleep disordered breathing based on phone interview

Publications:
Responsible Party: Edward Bixler, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00005296     History of Changes
Other Study ID Numbers: 2019
R01HL040916 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases